With EO 121, FDA can issue authority to use “safe and effective” foreign FDA registered vaccines within 21 to 28 days
(Eagle News) – President Rodrigo Duterte has signed an executive order granting Emergency Use Authorization (EUA) for drugs and vaccines for COVID-19 paving the way for the early use of COVID-19 vaccines with proven efficacy and safety.
President Duterte signed Executive Order (EO) No. 121 on Tuesday, Dec. 1, which authorizes the Food and Drug Administration (FDA) to fast-track the procurement and use of drugs and vaccine against COVID-19, especially those which have shown efficacy and safety, so these could already be administered to the public.
With the emergency use authorization, FDA can issue an authority to use such vaccines within 21 to 28 days, instead of the usual six months.
“Nilagdaan po ng ating Presidente Rodrigo Roa Duterte ang Executive Order No. 121 noong Martes, a-uno ng Disyembre, kung saan binibigyan otoridad ang Food and Drug Administration, or FDA, na magbigay ng Emergency Use Authorization para sa gamot at bakuna laban sa COVID-19,” said Presidential Spokesperson Secretary Harry Roque at a press briefing on December 3.
“Kung magkakaroon ng emergency use utilization ay yung mga rehistrado sa mga foreign FDA na mga bakuna, mapapabilis po ang pag-issue ng authority to use it under EUA to 21 days. Normally po kung wala itong Executive Order na ito it will take as long as six months,” he explained.
Roque said that the EUA will only be applicable amid these trying times of the pandemic, when there is a declared public health emergency.
-FDA directed to form panel of experts to review COVID vaccines-
The President also directed the FDA to form a panel of experts on drugs and vaccine development to review data on which vaccines that applied for emergency use authorization are safe and effective.
FDA Director-General Eric Domingo said that pharmaceutical companies that have applied and are expected to apply for Philippines’ approval for emergency use authorization are Pfizer, Sinovac, Sinopharm, Moderna, and AstraZeneca.
Once these companies have been granted approval for EUA by the United Kingdom and the United States, then they may start to apply for the same issuances in other countries as well, Domingo explained.
“Mauuna siguro iyong mga mayroon ng EUA katulad ng Pfizer, baka po itong mga Sinovac, Sinopharm, Moderna at AstraZeneca – ito po iyong mga nag-apply na. At kapag nag-apply po sila sa atin, within 21 to 28 days ay mabibigyan po natin ng approval or desisyon po ‘no kung approved or disapproved ang kanilang application,” he observed.
-Conditions that should be met before emergency use authorization-
According to the EO 121, the following conditions should be present to be given an EUA:
1. Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
2. The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any;
3. And there is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19.
Malacang said this development would be good for the country as it fights the pandemic.
“Of course, makakabuti po yan, dahil itong mga bakuna naman po hindi bibigyan ng EUA kung hindi po napatunayan sa clinical trials na ito po ay ligtas at epektibo laban po sa COVID-19. So yan po ang solusyon sa ating pandemya, ang pagkakaroon ng bakuna ng tayo po ay makabalik sa ating pong mga ordinaryong pamumuhay,” Roque said.
The Philippine government targets mass vaccination against COVID-19 in the country by the second quarter of next year.
It plans to give at least 60 million Filipinos, particularly those among the poorest of the poor and the country’s frontliners and first responders, including doctors, nurses, soldiers and policemen, free vaccines.
(Eagle News Service)